safety and performance of regenera breast implant in women affected by malignant breast lesion treated by lumpectomy

Conditions: Mastectomy, Segmental; Breast Neoplasm Malignant Female

Summary: the goals of this clinical trial are: * demonstrate the safety of regenera breast implant in patients undergoing lumpectomy of malignant breast lesions * demonstrate the safety and performance of regenera in terms of investigator's satisfaction, potential interference with current standard-of-care imaging techniques and occurrence of device-related serious adverse events.

participants will perform 13 study visits, and at each visit, all necessary study procedures will be performed according to the clinical investigation plan: * screening * pre-surgery treatment * surgery and study device implant * post-surgery follow-up up to 5 years

Eligibility criteria:
inclusion criteria: * female adult subject aged 40-70 years. * subject diagnosed with malignant breast lesion: * monolateral nodular infiltrative carcinoma, * without microcalcification, * single or multifocal, * included in an area with a maximum diameter of 4 cm, * non-metastatic (m0). * subject with clinically negative axilla. * subject considered eligible for conservative breast surgery - bcs (breast-conserving surgery, lumpectomy or quadrantectomy), leaving a volume deficit compatible with a regenera implant (available in two dried sizes) volume of 70 ml or 100 ml. * confirmation of malignant lesion (pt1, pt2, pn0, pn1) with no discordance between biopsy and radiological imaging. * adequate hematopoietic functions. * good general health and mentally sound. * subject able and willing to give written informed consent form. exclusion criteria: * subject with actual concomitant benign breast lesion (b2 and b3), unless present in the same mammary quadrant or in the contralateral breast. * subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or paget's disease. * axillary dissection planned as part of the breast lesion surgery. * history of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast parenchyma object of the study. * skin retraction at the breast to be operated. * infection of the surgical site confirmed pre-operatively by clinical examination. * abnormal blood sugar and glycosylated hemoglobin. * hard smoker (more than 10 cigarettes a day). * acute or chronic severe renal insufficiency (creatinine values \>180 μmol/l). * history of severe asthma or allergies (including allergy to anesthetics or contrast media). * autoimmune disease. * subjects who are known to be carriers of bcra mutation. * inability to undergo mri or allergy to contrast media. * systemic infections in an active phase. * immunocompromised patients (hiv). * pregnant or breastfeeding woman or woman who has nursed a child within 3 months prior to enrolment in the study. * subject who has participated in another interventional study within the past 3 months. * subject who received immunosuppressant therapy in the last 3 months. * history of substance abuse (drug or alcohol). * non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).